Continuous Real Time CSF Shunt Flow Monitor ShuntCheck

连续实时脑脊液分流监测仪 ShuntCheck

• 批准号: 8520078
• 负责人: Frederick J Fritz
• 金额: $ 47.47万
• 依托单位: NEURODX DEVELOPMENT, LLC
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-05-01 至 2015-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8520078
• 关键词: Abbreviations; Abdomen; Address; Adult; Affect; American; Animal Model; Animal Testing; Animals; Brain Death; Brain Injuries; Businesses; Cerebral Ventricles; Cerebrospinal Fluid; Cerebrospinal fluid shunts procedure; Childhood; Clinic; Clinical; Clinical Management; Clinical Research; Complex; Computers; Contracts; Data Security; Device or Instrument Development; Devices; Diagnosis; Diagnostic; Drainage procedure; Electronics; Emergency Situation; Exposure to; Failure; Foundations; Generations; Goals; Headache; Health Care Costs; Heating; Holter Electrocardiography; Hospitals; Human; Hydrocephalus; Infection; Laboratories; Link; Manufacturer Name; Marketing; Medical Device; Methods; Modeling; Monitor; Nausea; Normal Pressure Hydrocephalus; Obstruction; Outpatients; Patients; Pediatric Hospitals; Performance; Phase; Procedures; Production; Pump; Radiation; Radioisotopes; Reporting; Research; Risk; Running; Safety; Sales; Shunt Device; Small Business Innovation Research Grant; Symptoms; System; Tablets; Technology; Testing; Time; United States; United States National Institutes of Health; Wireless Technology; Work; X-Ray Computed Tomography; base; cost effectiveness; design; detector; digital; ergonomics; exhaust; experience; improved; innovation; journal article; meetings; neurosurgery; novel diagnostics; phase 1 study; prototype; public health relevance; sensor; tool; user friendly software

DESCRIPTION (provided by applicant): This Phase II SBIR will develop Continuous Real Time (CRT) ShuntCheck, the first portable, non- invasive device for real time, continuous monitoring of changes in flow in CSF shunts. This device will result in improved clinical management of hydrocephalus by providing a non-invasive method for monitoring and researching shunt function. Hydrocephalus, a common condition in which CSF accumulates in the brain ventricles, is corrected by placing a VP shunt that drains excess CSF to the abdomen. Shunts frequently malfunction, usually by obstruction, but the symptoms of shunt failure are unspecific - headache, nausea. Diagnosis of shunt malfunction is expensive and presents risks (exposure to radiation from CT Scans, risk of infection from radionuclide testing). Additionally, ongoing clinical management of shunted patients is complex (due to a lack of tools for investigating CSF over drainage, for assessing the performance of specific shunt valves and siphon control devices and for streamlining the adjustment of programmable shunt valves). NeuroDx's existing device, ShuntCheck-Micro-Pumper, is a shunt obstruction detector and addresses the need for a non-invasive test for shunt malfunction. While this makes it a valuable tool for the Emergency Dept, the short duration of the test limits its utility for shunt valve adjustment, investigating suspected shunt over drainage, etc. A non-invasive, non-radiologic device which can track changes in CSF flow rate would address many ongoing clinical management needs and become a valuable tool for the neurosurgery clinic. In our Phase I studies, we developed a laboratory prototype CRT based upon a breakthrough innovation in our thermal dilution technology and validated its safety and accuracy in bench and animal studies. CRT can reliably differentiate between no, low and robust shunt flow and can track changes in shunt flow rates over extended time periods. The goal of this Phase II project is to refine CRT ShuntCheck from a laboratory prototype to a production-ready device, validate its safety and accuracy in bench and animal testing, and complete a 510k submission for FDA clearance. Post-Phase II clinical studies will demonstrate the clinical utility and cost effectiveness of CRT ShuntCheck for streamlining valve adjustment in pediatric and in adult NPH patients. NeuroDx's business model for this product involves the generation of revenue primarily from the ongoing sale of single-use, disposable sensors for these tests. Shunt management testing constitutes approximately 105,000 shunt flow tests annually in the United States alone. The need for new diagnostic tools for managing hydrocephalus patients is highlighted by the NIH announcement "Advanced Tools and Technologies for Cerebrospinal Fluid Shunts" (PA-09-206), to which this application is responding. Our application directly responds to the request for Diagnostic tools for use in a hospital or outpatient setting that work in real-time to quantitatively determine shun function.

描述（由申请人提供）：此II阶段SBIR将开发连续实时（CRT）Shuntcheck，这是第一个用于实时的便携式，非侵入性设备，连续监视CSF分流器流量的变化。该设备将通过提供一种非侵入性方法来监测和研究分流功能，从而改善脑积水的临床管理。脑积水是CSF在脑室中积累的常见状况，通过将副总裁分流器放置在腹部中，可以纠正脑心室。分流经常出现故障，通常是由于障碍物而出现的，但是分流衰竭的症状是不明确的 - 头痛，恶心。分流故障的诊断很昂贵，并且会出现风险（CT扫描受到辐射，放射性核素测试感染的风险）。此外，持续的分流患者的临床管理很复杂（由于缺乏用于研究CSF在排水方面的工具，用于评估特定分流阀和虹吸器控制设备的性能以及简化可编程分流阀的调整）。 NeuroDX现有的设备Shuntcheck-Micro-Pumper是分流阻塞探测器，并解决了对分流故障的非侵入性测试的需求。虽然这使其成为紧急部门的宝贵工具，但测试的短持续时间限制了其实用程序对流量阀调节的效用，调查可疑的排水管上的分流等。一种非侵入性的，非放射线的设备，可以跟踪CSF流量的变化，可以满足许多持续的临床管理需求，并成为神经疗养院临床的有价值工具。在我们的第一阶段研究中，我们根据热稀释技术的突破性创新开发了实验室原型CRT，并验证了其在板凳和动物研究中的安全性和准确性。 CRT可以可靠地区分NO，低和强大的分流流，并可以在延长的时间段内跟踪分流流速的变化。该阶段II项目的目标是将CRT Shuntcheck从实验室原型改为生产准备设备，验证其在板凳和动物测试中的安全性和准确性，并完成510K提交以进行FDA清除率。第三相后的临床研究将证明CRT Shuntcheck的临床实用性和成本效益用于简化小儿和成年NPH患者的瓣膜调节。 NeuroDX为该产品的业务模型涉及主要来自持续出售这些测试的一次性，一次性传感器的收入。仅在美国，分流管理测试每年大约构成大约105,000个分流流程测试。 NIH公告“用于脑脊液分流器的高级工具和技术”（PA-09-206）强调了对管理脑积水患者的新诊断工具的需求。我们的应用程序直接响应用于实时工作的医院或门诊设置的诊断工具的请求，以定量确定避难功能。